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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Collaborator: |
Neurologic AIDS Research Consortium (NARC) |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00050271 |
Purpose
The purpose of this study is to determine if acetyl-L-carnitine (ALC) reduces pain, numbness, and tingling in the feet and legs of patients with nucleoside reverse transcriptase inhibitor (NRTI)-associated peripheral neuropathy. Another purpose is to determine if ALC is safe and tolerable in HIV patients who have taken certain anti-HIV drugs.
| Condition | Intervention |
|---|---|
|
HIV Infections Peripheral Nervous System Diseases |
Drug: Acetyl-L-carnitine |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label, Dose-Escalation Pilot Study of Acetyl-L-Carnitine for the Treatment of Dideoxynucleoside-Associated Distal Symmetric Peripheral Neuropathy |
| Estimated Enrollment: | 36 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Distal symmetric peripheral neuropathy (DSPN) is the most frequent neurologic complication of HIV infection and its treatments. NRTIs, particularly dideoxy-NRTIs, represent a significant risk factor for developing neuropathy. To date, there are no effective treatments for DSPN. Studies of nonneuronal tissues indicate a beneficial effect of ALC in HIV-1 seropositive individuals, but the role of ALC levels in patients with DSPN is unclear. Despite conflicting data, carnitine and its derivatives are still commonly used.
Patients will have a screening visit and visits at entry and Weeks 6, 12, 18, and 24. Patients are required to fast (no food or drink except water) for 4-12 hours for the screening visit, entry visit, and at Weeks 12 and 24. Targeted physical examinations, blood chemistries, liver function tests, HIV-1 RNA, CD4/CD8 cell counts, hematology, and lactate assessments will be done. Patients will also have a small skin biopsy at entry and Week 24. Patients will begin with 1 tablet of ALC twice daily and escalate dosage to a target dose of 3 tablets daily. They will remain on the 3-tablet dose or a maximum tolerated dose for the duration of the study (24 weeks).
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Univ of Texas, Southwestern Med Ctr | |
| Sacramento, California, United States, 95814 | |
| University of California, San Diego Antiviral Research | |
| San Diego, California, United States, 92103 | |
| Stanford Univ | |
| Stanford, California, United States, 94305 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Illinois | |
| Cook County Hosp Core Ctr | |
| Chicago, Illinois, United States, 60612 | |
| Northwestern Univ | |
| Chicago, Illinois, United States, 60611-3015 | |
| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21287-8106 | |
| University of Maryland, Institute of Human Virology | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Missouri | |
| Washington University (St. Louis) | |
| St. Louis, Missouri, United States, 63108-2138 | |
| United States, New York | |
| Mount Sinai Med Ctr | |
| New York, New York, United States, 10029 | |
| The Cornell Clinical Trials Unit | |
| New York, New York, United States, 10021 | |
| Beth Israel Med Ctr | |
| New York, New York, United States, 10003 | |
| United States, Texas | |
| Univ of Texas, Galveston | |
| Galveston, Texas, United States, 77555-0435 | |
| United States, Washington | |
| Univ of Washington (Seattle) | |
| Seattle, Washington, United States, 90033-1079 | |
| Puerto Rico | |
| .University of Puerto Rico | |
| San Juan, Puerto Rico, 00936-5067 | |
| Study Chair: | Victor Valcour, M.D. | University of Hawaii |
| Study Chair: | Russell Bartt, M.D. | Cook County Hospital and Rush-Presbyterian St. Luke's Medical Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00050271 History of Changes |
| Other Study ID Numbers: | ACTG A5157 |
| Study First Received: | December 3, 2002 |
| Last Updated: | February 28, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Acetylcarnitine Dideoxynucleosides Epidermis Biopsy |
Immunohistochemistry Nerve Fibers Treatment Experienced |
|
HIV Infections Acquired Immunodeficiency Syndrome Nervous System Diseases Peripheral Nervous System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Neuromuscular Diseases Acetylcarnitine |
Carnitine Dideoxynucleosides Nootropic Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents |